FDA.reportPublic FDA data

PRAX

Product NDC
0496-0748
11-digit product format
004960748
Labeler code
0496
Product ID
0496-0748_297a2f2f-8355-6e34-e063-6394a90add60
Type
HUMAN OTC DRUG
Nonproprietary name
pramoxine hydrochloride
Dosage form
LOTION
Route
TOPICAL
Labeler
Ferndale Laboratories, Inc.
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-04-01
Substance
PRAMOXINE HYDROCHLORIDE
Active strength
10 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
PRAX
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PRAMOXINE HYDROCHLORIDE10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii88AYB867L5
Rxcui1246075, 1246076

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0496-0748-03PRAX237 mL in 1 BOTTLELOTION2373
0496-0748-04PRAX118 mL in 1 BOTTLELOTION1183
0496-0748-15PRAX15 mL in 1 BOTTLELOTION153

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0496-0748-03ML - Milliliter0496-0748b6504dad-0912-4d55-9453-e5d6c6a530c012013-07-02
0496-0748-04ML - Milliliter0496-0748b54a913e-a7ae-4fa8-ac21-94664fed7c1b12013-07-02
0496-0748-15ML - Milliliter0496-074804165e3a-56fa-4666-879e-9ba45270066812013-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PRAMOXINE HYDROCHLORIDEACTIVE INGREDIENT88AYB867L5PRAX (PRAMOXINE HYDROCHLORIDE) LOTION [FERNDALE LABORATORIES, INC.]1
PRAMOXINEACTIVE MOIETY068X84E056PRAX (PRAMOXINE HYDROCHLORIDE) LOTION [FERNDALE LABORATORIES, INC.]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNPRAX (PRAMOXINE HYDROCHLORIDE) LOTION [FERNDALE LABORATORIES, INC.]1
DIISOPROPYL ADIPATEINACTIVE INGREDIENTP7E6YFV72XPRAX (PRAMOXINE HYDROCHLORIDE) LOTION [FERNDALE LABORATORIES, INC.]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OPRAX (PRAMOXINE HYDROCHLORIDE) LOTION [FERNDALE LABORATORIES, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXPRAX (PRAMOXINE HYDROCHLORIDE) LOTION [FERNDALE LABORATORIES, INC.]1
HYDROGENATED COCONUT OILINACTIVE INGREDIENTJY81OXM1OMPRAX (PRAMOXINE HYDROCHLORIDE) LOTION [FERNDALE LABORATORIES, INC.]1
LANOLININACTIVE INGREDIENT7EV65EAW6HPRAX (PRAMOXINE HYDROCHLORIDE) LOTION [FERNDALE LABORATORIES, INC.]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPPRAX (PRAMOXINE HYDROCHLORIDE) LOTION [FERNDALE LABORATORIES, INC.]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UPRAX (PRAMOXINE HYDROCHLORIDE) LOTION [FERNDALE LABORATORIES, INC.]1
POLYOXYL 40 STEARATEINACTIVE INGREDIENT13A4J4NH9IPRAX (PRAMOXINE HYDROCHLORIDE) LOTION [FERNDALE LABORATORIES, INC.]1
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4PRAX (PRAMOXINE HYDROCHLORIDE) LOTION [FERNDALE LABORATORIES, INC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EPRAX (PRAMOXINE HYDROCHLORIDE) LOTION [FERNDALE LABORATORIES, INC.]1
SORBIC ACIDINACTIVE INGREDIENTX045WJ989BPRAX (PRAMOXINE HYDROCHLORIDE) LOTION [FERNDALE LABORATORIES, INC.]1
SORBITAN SESQUIOLEATEINACTIVE INGREDIENT0W8RRI5W5APRAX (PRAMOXINE HYDROCHLORIDE) LOTION [FERNDALE LABORATORIES, INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPRAX (PRAMOXINE HYDROCHLORIDE) LOTION [FERNDALE LABORATORIES, INC.]1
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YPRAX (PRAMOXINE HYDROCHLORIDE) LOTION [FERNDALE LABORATORIES, INC.]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKPRAX (PRAMOXINE HYDROCHLORIDE) LOTION [FERNDALE LABORATORIES, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RPRAX (PRAMOXINE HYDROCHLORIDE) LOTION [FERNDALE LABORATORIES, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0496-0748PRAX (PRAMOXINE HYDROCHLORIDE) LOTION [FERNDALE LABORATORIES, INC.]3Current NDC, Legacy NDC, 3 package rows20241219_674f0d8b-3d50-42b1-8401-d2967bcdf5cf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1246075pramoxine HCl 1 % Topical LotionPSN674f0d8b-3d50-42b1-8401-d2967bcdf5cf3
1246076Prax 1 % Topical LotionPSN674f0d8b-3d50-42b1-8401-d2967bcdf5cf3
1246076pramoxine hydrochloride 10 MG/ML Topical Lotion [Prax]SBD674f0d8b-3d50-42b1-8401-d2967bcdf5cf3
1246075pramoxine hydrochloride 10 MG/ML Topical LotionSCD674f0d8b-3d50-42b1-8401-d2967bcdf5cf3
1246075pramoxine hydrochloride 1 % Topical LotionSY674f0d8b-3d50-42b1-8401-d2967bcdf5cf3
1246076Prax 1 % Topical LotionSY674f0d8b-3d50-42b1-8401-d2967bcdf5cf3
1246076Prax 10 MG/ML Topical LotionSY674f0d8b-3d50-42b1-8401-d2967bcdf5cf3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0496-0748-0300496074803237 mL in 1 BOTTLE (0496-0748-03) 237 ml2012-04-010000-00-00NoNoCurrent
0496-0748-0400496074804118 mL in 1 BOTTLE (0496-0748-04) 118 ml2012-04-010000-00-00NoNoCurrent
0496-0748-150049607481515 mL in 1 BOTTLE (0496-0748-15) 15 ml2012-04-010000-00-00NoNoCurrent